A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE)
Sponsor: Intercept Pharmaceuticals
Enrolling: Male and Female Patients
IRB Number: AAAP9467
U.S. Govt. ID: NCT02548351
Contact: Claudia Musat: (212) 305-3839 / cm2065@cumc.columbia.edu
Additional Study Information: This is a research study in patients with nonalcoholic steatohepatitis (NASH) (inflammation and damage in the liver due to buildup of fat in the liver) and some liver fibrosis (scarred liver tissue). The purpose of this study is to find out how safe and effective the study drug, Obetcholic Acid (OCA), may be in delaying liver fibrosis and other specific medical conditions or health related issues that can occur in these patients.
This study is closed
Investigator
Thresiamma Lukose
Do You Qualify?
Are you at least 18 years old? Yes No
Do you have a diagnosis of "NASH" , "NAFLD", or "Fatty Liver Disease"? Yes No
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For more information, please contact:
Claudia Musat
cm2065@cumc.columbia.edu
(212) 305-3839
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